Catalog Number

310.10

Brand Name

VYGON

Version/Model Number

310.10

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 20, 2018

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KNT

Product Code Name

TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Public Device Record Key

d5084390-edc6-4578-8d7c-93911f833a3d

Public Version Date

May 13, 2020

Public Version Number

5

DI Record Publish Date

September 09, 2016

Package DI Number

53660812003617

Quantity per Package

12

Contains DI Package

33660812003613

Package Discontinue Date

July 20, 2018

Package Status

Not in Commercial Distribution

Package Type

-